NCT05016804TerminatedPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Reason given: Inadequate treatment response observed in preliminary data did not justify enrolling further study participants
Brief summary (registry, in English)
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Aug 2021
- Start date
- 4 Jul 2022
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05016804
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Continued drug abuse
- Previous organ transplant
Other illness
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- Hypersensitivity to sulfur
Lab values
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
Other
- Pregnancy
- Pre-menopausal women not using contraception
Who the study is looking for
- Diagnosis of Systemic Sclerosis
- Understanding and willingness to sign a written informed consent document
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Surgical Associates Center | St John's | Antigua & Barbuda | Unknown status |
| Center for Investigation in Tissue Engineering and Cellular Therapy | Buenos Aires | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.